Status:
COMPLETED
Assessment of the Neuro-glio-epithelial Unit (NGEU) in Biopsies Taken During Peroral Endoscopic Myotomy (POEM) for Achalasia: a Feasibility and Safety Study.
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Rennes University Hospital
University Hospital, Angers
Conditions:
Esophageal Achalasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Achalasia is a primary esophageal motility disorder characterized on high-resolution manometry (HRM) studies by 100% failed peristalsis and elevated integrated relaxation pressure of the lower esophag...
Eligibility Criteria
Inclusion
- Male or female 18 years and above;
- Woman of child-bearing age, if using active (oral contraceptive pill, intrauterine device, contraceptive implant) and/or mechanical (condom, diaphragm) contraceptive method;
- Treatment-naive (no pneumatic dilation, botox injection, Heller's myotomy) patient with HRM-diagnosed achalasia in whom POEM is indicated;
- Thorough oral and written information about the protocol has been provided and patient's consent to participate in the study has been obtained;
- The patient is insured under the French social security system.
Exclusion
- Active anticoagulant treatment or coagulation disorder
- Past history of achalasia treatment (pneumatic dilation, botox injection, Heller's myotomy)
- Pregnancy or breastfeeding
- Patient under trusteeship, guardianship, placed under judicial protection, and/or unable to provide consent
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04112693
Start Date
November 21 2019
End Date
November 13 2023
Last Update
February 7 2024
Active Locations (1)
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1
Nantes UH
Nantes, France